Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Alveolar Osteitis Clinical Trial

Official title:

Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853589
• Other study ID #: 1049/2021
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2022
• Source: Medical University of Vienna
• Contact: Danijel Domic, DMD
• Phone: +4369917230592
• Email: Danijel.domic[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. > 18 years;

2. Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);

3. Diagnosis of AO based on the criteria of Blum (Blum 2002)

Exclusion Criteria:

4. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;

5. Pregnancy;

6. History of hypersensitivity or allergy to HY;

7. Inability to attend follow-up appointments; Intake of preoperative antibiotics.

Related Conditions & MeSH terms

• Alveolar Osteitis
• Dry Socket
• Osteitis

Intervention

Device:
• Hyaluronic acid gel
After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 1 will receive hyaluronic acid gel.
• Hyaluronic acid gel + carrier
After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 2 will receive hyaluronic acid gel together with a collagen carrier.

Locations

Country	Name	City	State
Austria	University Clinic of Dentistry, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception by the patient	VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain	2 weeks